Efficacy to Effectiveness (E2E) trial design is an approach in which an effectiveness trial would commence on completion of the efficacy trial. E2E trials are designed to address the effectiveness and safety gaps that often occur in standard randomized controlled trials, and offer an opportunity for improved understanding of how a treatment will work in real-world clinical settings.
CTSA investigators can explore how an E2E Trial Design can improve their research through two opportunities with the Trial Innovation Network.
E2E Design Lab: March 2018
The MIT NEWDIGS program and JHU-Tufts Trial Innovation Center are hosting a two-day E2E Design Lab in March 2018. Participants at this event will discuss the considerations and challenges of designing a Phase 2 or Phase 3 E2E multi-site clinical trial that generates robust efficacy and effectiveness data. Registration deadline is September 15, 2017.
Investigators can also apply for E2E Consultations, which offer a dedicated, protocol-specific approach to E2E trial design, focusing on the selection of suitable efficacy and effectiveness endpoints, advice on the statistical analysis plan, and the role of the DSMB in transitioning from the efficacy to effectiveness phase.
This information was provided by the JHU-Tufts Trial Innovation Center. Please direct questions to the JHU-Tufts Trial Innovation Center Project Lead, Sheeona Gorman, PhD: email@example.com.